MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC DUAL LUMEN PERIPHERAL INSERTED CENTRAL CATHETER KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	P2PIC1.9-S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A double lumen umbilical venous catheter was placed in an infant.Upon connecting the medications, they noted a large amount of air in the catheter.A small leak was noted in one of the lumens.The line was removed and replaced.Fda safety report id # (b)(4).

• Brand Name: DUAL LUMEN PERIPHERAL INSERTED CENTRAL CATHETER KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): FOOTPRINT MEDICAL INC; san antonio TX
• MDR Report Key: 11912808
• Report Number: MW5101638
• Device Sequence Number: 2995027
• Product Code: LJS
• UDI-Device Identifier: 00858778006102
• UDI-Public: (01)00858778006102
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2022
• Device Model Number: P2PIC1.9-S
• Device Catalogue Number: P2PIC1.9-S
• Device Lot Number: 200500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 1